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Sr. Manager, QA for QC

Company: bluebird bio
Location: Cambridge
Posted on: November 18, 2021

Job Description:

On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business ("Oncology Newco") as a new entity, with the completed transition expected by the end of 2021.

About The Nest

At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

About The Flock

This QA flock is responsible for the QA GMP oversight of laboratory testing performed at third party Contract Laboratory Organizations (CLO). This role supports the organization by leading a team collaborating with the Quality Control Integrated Operations (QCIO) function to ensure bluebird bio products meet required specifications for safety, potency, and efficacy through the lifecycle of the product. The Senior Manager has oversight of lab investigations, OOS, change controls, stability protocols and reports, expiry extensions, and resolution of quality systems and escalations encountered while testing bluebird bio products. This position liaises with internal and external teams for applicable pre-approval inspection preparation and execution at bluebird bio CMO's and CLO's in support of a bluebird bio intended commercial product. Come fly with us as we strive to make a difference in the lives of patients and their families!

How You'll Fly

You'll help to bring more patients their bluebird days by:

  • Partnering with teams internally and externally to develop/execute successful analytical testing methods, during batch production/testing and pre-licensing inspection (PLI) preparation
  • Ensuring an appropriate and consistent approach in quality expectations of CMOs/CLOs, including establishment of Quality Agreement, external quality oversight and escalation related to bluebird bio's review and approval of technical protocols and reports, deviations, CAPA, Change Control, Out of Specifications (OOS), lab investigations
  • Managing adherence to scheduled timelines for bluebird bio product release/disposition, ensuring compliant QA disposition of batches, including applicable post-release quality event batch oversight
  • Preparing KPI data via review, analysis, and identification of trends of quality system records at CMOs/CLOs and providing periodic updates to Quality Leadership
  • Reviewing and approving internal and external documentation, ensuring compliance with applicable US and EU cGMP regulations and industry standards and guidelines
    What You'll Bring

    You're the bird we're looking for if you have:
    • BA/ BS in a scientific discipline and a minimum of 8+ years in Quality Assurance
    • Experience with managing contract manufacturing and/or testing organizations, including quality agreement negotiation and recognition as an external influential thought-leader
    • Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence
    • In-depth and breadth of expertise in analytical disciplines including method validation, method transfer, critical reagents, OOS investigations, stability, product expiry extensions aligning with agency expectations
    • Solid understanding and experience with analytical methods, investigations, change control, and process qualification and validation
    • Strong knowledge of GxP regulations, quality systems, risk management and regulatory guidance documents in US (and EU, preferred) including ICH Q7, Q8, Q9 and Q10
    • Experience with Sharepoint, Veeva eQMS, Visio, and excel based programs a plus
      All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.

      bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

      bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Keywords: bluebird bio, Cambridge , Sr. Manager, QA for QC, Executive , Cambridge, Massachusetts

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